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CompletedNCT05032508SAUTYLOUpdated May 6, 2026

Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger

A Phase 4 interventional study of Lidocaïne Aguettant 20 mg/ml and NaCl 0,9% in Trigger Finger, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger

Read the detailed description

Trigger finger ultrasound-guided infiltrations are frequent and painful invasive procedures.

However, there is no current recommendation for per-procedural pain management, and in the majority of cases, infiltration is performed without prior skin anesthesia.

Xylocaine patches are of controversial efficacy in pain acute management. In current practice, they are not prescribed in advance and they are not well adapted to the topography of the finger.

On the other hand, a recent study showed the interest of administering lidocaine 2% by J-tip, a needle-free injection technique not available in France, before infiltration of Trigger Finger.

The investigators hypothesize that an impregnated compress in Xylocaine 20 mg/ml injectable solution, applied 15 minutes before the procedure, would reduce per-procedural pain.

02

Conditions studied

  • Trigger Finger

Keywords

  • Trigger Finger
  • Xylocaine
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's enrollment of 60 is close to the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older
  • Trigger Finger (clinically defined by painful difficulty or protrusion when extending the finger) with an ultrasound-guided infiltration of cortisone derivatives indication.
  • Written consent
  • Affiliation to a Social Security system
  • Prior medical examination

Exclusion criteria

Exclusion Criteria:

  • Neurological conditions affecting the hand other than carpal tunnel syndrome
  • Intra-articular infiltration of the hand or the wrist ≤ 2 months
  • Allergy to Xylocaine
  • to Xylocaine or cortisone derivatives
  • Cognitive or behavioral disorders that make assessment impossible
  • Persons referred to in articles L 1121-5; 6; 8; 9 of the Public Health Code (protected adults, under guardianship or curatorship, etc)
  • Pregnancy and breastfeeding; absence of method for women of childbearing age
  • Participant unable to speak, read and write French
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    xylocaine

    Drug: Lidocaïne Aguettant 20 mg/ml

  • Placebo comparator
    Placebo

    Drug: NaCl 0,9%

Interventions

  • DrugLidocaïne Aguettant 20 mg/ml

    Lidocaïne Aguettant 20 mg/ml, injectable solution, applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.

  • DrugNaCl 0,9%

    Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.

06

What researchers measure

Primary outcomes

  1. Average pain intensity during the ultrasound-guided infiltration.

    Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).

    Time frame: Day 0, immadiately after infiltration

Secondary outcomes

  1. Adverse Events

    Adverse events based on a self-administered open-ended question

    Time frame: Day 0

  2. Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration

    Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable).

    Time frame: Day 0

  3. Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger

    Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).

    Time frame: Day 0

07

Study locations

1 site
  • Cochin hospital
    Paris, 75014, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05032508
Collaborators
Fondation de l'Avenir, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Sep 2, 2021
Start date
Jun 7, 2022
Primary completion
Jun 7, 2023
Completion
Jun 7, 2023
Last update
May 6, 2026

Study contacts

Henri GUERINI, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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